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Breast CancerPhase 1/2INX-315-01NCT05735080

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

A Phase 1/2 study testing INX-315, Fulvestrant and Abemaciclib in people with Breast Cancer and Breast Cancer Metastatic, run by Incyclix Bio at 18 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
INX-315, Fulvestrant and Abemaciclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
18 sitesin 2 countries
Study dates
28 Mar 2023to Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced unresectable or metastatic HR+/HER2- BC that has progressed following treatment with a CDK4/6 inhibitor in the adjuvant or advanced/metastatic setting.
  • Advanced/ metastatic platinum-resistant or platinum-refractory high grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with known amplification of CCNE-1 that progressed after standard systemic therapy
  • Advanced or metastatic solid tumor with known amplification of CCNE-1 that has progressed after standard therapy, been intolerant to or is ineligible for standard therapy
  • At least one measurable lesion as defined by RECIST v1.1 that has not previously been irradiated
  • ECOG performance status score of 0 or 1.
  • Adequate organ function as demonstrated by the following laboratory values:
Show all 12Show fewer
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
  • Platelet count ≥ 100 × 10^9/L
  • Estimated glomerular filtration rate (eGFR) of ≥60 mL/min
  • Part A and B: Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; ≤ 5 × ULN in the presence of liver metastases Part C: Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 × ULN and direct bilirubin within normal limits
  • Negative pregnancy test

Who cannot join

  • Have received previous therapy with a CDK2/4/6 inhibitor or CDK2 inhibitor.
  • Have central nervous system (CNS) metastases or spinal cord compression that is associated with progressive neurological symptoms or requires corticosteroids (within 4 weeks of enrollment) to control the CNS disease.
  • Have known intracranial hemorrhage and/or bleeding diatheses.
  • Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
  • Have clinically active ongoing interstitial lung disease (ILD) of any etiology, including drug-induced ILD, and radiation pneumonitis within 28 days prior to initiation of study treatment.
  • Resting QTcF > 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.
Show all 20Show fewer
  • Uncontrolled, cardiovascular disease (including hypertension) with or without medication
  • History of other malignancies, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for ≥ 3 years.
  • Known HIV infection, including AIDS-related illness, or have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus, hepatitis C virus, or COVID-19 infection (symptoms and a positive test result).
  • Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.
  • Have planned or anticipation of the need for major surgical procedure within 28 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures).
  • Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.
  • Radical radiotherapy within 28 days prior to study entry or palliative radiotherapy within 2 weeks prior to study entry.
  • Systemic anti-cancer therapy within 21 days or at least 5 half-lives, whichever is less, prior to the first dose of the study drug
  • Prior irradiation to > 25% of the bone marrow
  • Previous high-dose chemotherapy requiring prior stem cell transplant
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry.
  • Known or suspected hypersensitivity to active ingredient/excipients in INX-315 or fulvestrant or abemaciclib.
  • Known difficulty in swallowing or tolerating oral medications, or conditions which would impair absorption of oral medications such as active inflammatory gastrointestinal disease, uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder/active inflammation, malabsorption syndrome, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.
  • Has a serious and/or uncontrolled pre-existing medical condition(s) that, in the judgment of the Investigator or the Sponsor, would preclude participation in this study (for example but not limited to, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)

Trial locations and contacts

18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Director contact

1-919-328-0003

clinicalinfo@incyclixbio.com

18 sites in 2 countries

United States15 sites, 15 recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

    Kevin M Kalinsky, MD

    Recruiting

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

    Donna Wheatley, dwheatley@augusta.edu

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Meghan Levesque, meghan_levesque@dfci.harvard.edu

    Antonio Giordano, MD

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Ask Roswell, 800-767-9355, AskRoswell@RoswellPark.org

    Sheheryar Kabraji, MD

    Recruiting

  • Gabrail Cancer Research Center

    Canton, Ohio, 44718

    Carrie Smith, RN, csmith@gabrailcancercenter.com

    Nashat Gabrail, MD

    Recruiting

  • Levine Cancer Institute (LCI)- Atrium Health

    Charlotte, North Carolina, 28204

    Antoinette Tan, MD

    Recruiting

  • Next Oncology

    Dallas, Texas, 75039

    Fope Akinwale, fakinwale@nextoncology.com

    Michael Song, MD

    Recruiting

  • UTSW Medical Center

    Dallas, Texas, 75390

    Isabel Valenciana, isabel.villobos@utsouthwestern.edu

    David Miller, MD

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Madeline McGinnis, 313-576-9380, mcginnism@karmanos.org

    Recruiting

  • Duke Cancer Center/ DUMC

    Durham, North Carolina, 27705

    Carey Anders, MD

    Recruiting

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

    Andrea Vasquez, andrea.vasquez@aoncology.com

    Sunil Babu, MD

    Recruiting

  • Oncology Consultants

    Houston, Texas, 77030

    Site PI, 713-600-0913, jpeguero@OncologyConsultants.com

    Julio Peguero, MD

    Not yet recruiting

  • Next Oncology

    Houston, Texas, 77054

    Fope Akinwale, fakinwale@nextoncology.com

    Jennifer Segar, MD

    Recruiting

  • Florida Cancer Specialists

    Orlando, Florida, 32827

    Julia Rivera Otero, Julia.RiveraOtero@Scri.com

    Cesar Perez, MD

    Recruiting

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

    Sue Quinsey, 253-428-8700, squinsey@nwmsonline.com

    Jorge Chaves, MD

    Recruiting

Other trials in United States

Australia3 sites, 3 recruiting

  • Peninsula and South Eastern Haematology & Oncology Group

    Frankston, Victoria, 3199

    Albert Goikhman, ag@paso.com.au

    Vinod Ganju, MD

    Recruiting

  • Peter MacCallum Cancer Center

    Parkville, Victoria, 3052

    Kim Nayeon, Nayeon.Kim@petermac.org

    George Au-Yeung, MD

    Recruiting

  • Mater Hospital

    South Brisbane, 4101

    Catherine Shannon, MD

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer

Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. The study will be conducted in 3 parts: Part A (INX-315 monotherapy dose escalation and combination therapy with fulvestrant), Part B (ovarian cancer INX-315 monotherapy dose expansion), and Part C (INX-315 combination therapy with abemaciclib [a CDK4/6i] and fulvestrant [a SERD] in advanced/metastatic breast cancer; dose escalation and expansion).

Read the detailed description

Study INX-315-01 is a first-in-human, Phase 1/2, open-label, dose escalation and dose-expansion study to evaluate the safety, PK, and preliminary antitumor activity of INX-315 in patients with advanced/metastatic cancers. The study will be conducted in 3 parts: Part A (dose escalation and combination therapy) and Part B (ovarian cancer dose expansion) and Part C (breast cancer dose escalation lead-in and expansion).

Part A is the dose-escalation portion of the study to evaluate the safety, tolerability, and PK of INX-315 monotherapy. Dosing decisions will be guided using a Bayesian optimal interval (BOIN) design. Up to 60 patients with recurrent advanced/metastatic cancer, including patients with HR+/HER2- breast cancer who progressed on a prior CDK4/6i regimen, and solid tumors, including ovarian cancer with known amplification of CCNE1 are planned to be enrolled in Part A.

Dose-limiting toxicities (DLTs) will be assessed during the first treatment cycle, i.e., the first 28 days of treatment (the DLT period). Patients who are evaluable for DLT assessment are those patients who are enrolled, received >=80% of the planned study drug doses during the DLT assessment period, and complete the 28-day DLT period.

Additionally, Part A will have two cohorts that will include INX-315 plus fulvestrant in HR+/HER2- patients who have have had prior treatment with CDK4/6i.

Part B will expand at least two dose levels determined by the SMC. Part B will enroll patients with platinum-refractory or platinum-resistant advanced/ metastatic ovarian cancer patients with CCNE1 amplifications. Part B will open for enrollment once the SMC has selected the dose levels to be evaluated from the Part A portion of the study. Part A patients cannot re-join or continue the study in Part B. Approximately 30 patients will be equally randomized to receive one of the dose levels of INX-315.

Part C will be a dose escalation and expansion cohort, patients with HR+/HER2- breast cancer will be enrolled in this cohort. Patients will receive INX-315 along with abemaciclib and fulvestrant. Approximately 50 patients will be enrolled in Part C.

Being tested
INX-315, Fulvestrant, Abemaciclib
Keywords
CDK2, CDK4/6i, cyclin dependent kinase 2, CCNE1
Medical subject headings
Breast Neoplasms, Ovarian Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INX-315Drug

    Oral administration

  • FulvestrantDrug

    Also called Faslodex

    Fulvestrant will be combined with INX-315

  • AbemaciclibDrug

    Also called Verzenio

    Abemaciclib will be combined with INX-315

Study groups in NCT05735080
Study groupRoleWhat they receive
Part A: Dose EscalationExperimentalMultiple doses of INX-315 monotherapy, oral administration
Receives: Drug: INX-315
Part B: Ovarian Dose ExpansionExperimentalINX-315 monotherapy, oral administration
Receives: Drug: INX-315
Part C: HR+/HER2- BC Dose ExpansionExperimentalINX-315 in combination with abemaciclib (oral administration) and fulvestrant (IM)
Receives: Drug: INX-315; Drug: Fulvestrant; Drug: Abemaciclib
Part A INX-315 + FulvestrantExperimentalINX-315 dose plus Fulvestrant 500mg (IM)
Receives: Drug: INX-315; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A and B: Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities in INX-315 monotherapy and in combination with fulvestrant

    Measured: Up to 12 months

  2. Part A: Evaluate the occurrence of dose-limiting toxicities (DLTs) during Cycle 1

    Measured: 28 days

  3. Part A: Recommend at least two doses of INX-315 to be evaluated in the expansion phase

    Measured: Up to 12 months

  4. Part B: Overall response rate (ORR)

    Measured: Up to 36 months

  5. Part B: Selection of Recommended Phase 2 Dose (RP2D)

    Measured: Up to 36 months

  6. Part C Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities for patients in combination treatment (INX_315+abemaciclib+fulvestrant)

    Measured: Up to 12 months

  7. Part C - Evaluate the antitumor activity of INX-315 in combination with abemaciclib and fulvestrant

    Measured: Up to 12 months

Secondary outcomes (12)

  1. Characterize the maximum plasma concentration (Cmax)

    Measured: Cycle 1 Day 1 and Day 15

  2. Characterize the time to maximum plasma concentration (Tmax)

    Measured: Cycle 1 Day 1 and Day 15

  3. Characterize the Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval (AUC0-24h)

    Measured: Cycle 1 Day 1 and Day 15

  4. Characterize the terminal half-life (t1/2)

    Measured: Cycle 1 Day 1 and Day 15

  5. Characterize the oral clearance (CL/F)

    Measured: Cycle 1 Day 1 and Day 15

  6. Part A: Overall response rate (ORR)

    Measured: Up to 36 months

  7. Disease control rate (DCR)

    Measured: Up to 36 months

  8. Progression free survival (PFS)

    Measured: Up to 36 months

  9. Duration of response (DOR)

    Measured: Up to 36 months

  10. Time to progression (TTP)

    Measured: Up to 36 months

  11. Overall survival (OS)

    Measured: Up to 36 months

  12. Part C Determine recommended dose of INX-315 in combination treatment for further study

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start28 Mar 2023
  3. Primary completionJul 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part A will be a dose escalation guided by BOIN design for treatment assignment and dosing rules. Part B will be a dose expansion phase, patients will be randomly assigned to receive one of the identified doses of INX-315 in monotherapy Part C will be a dose escalation followed by a dose expansion phase, patients will receive INX-315 in combination treatment with abemaciclib and fulvestrant
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05735080
Sponsor's protocol ID
INX-315-01
Acronym
INX-315-01
Status last verified
Mar 2026
First submitted
9 Feb 2023
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing INX-315, Fulvestrant and Abemaciclib in people with Breast Cancer and Breast Cancer Metastatic, run by Incyclix Bio at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Director (1-919-328-0003, clinicalinfo@incyclixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A and B: Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities in INX-315 monotherapy and in combination with fulvestrant (time frame: Up to 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05735080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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